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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03166111
Other study ID # LISITU
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 1, 2017
Est. completion date May 31, 2020

Study information

Verified date October 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date May 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion criteria:

- Non-pregnant women

- Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion

- Women who delivered only by caesarean section

Exclusion criteria:

- Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids

- Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use

- Allergy to lidocaine.

- Women refuse to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
lidocaine gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
placebo gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10 10 minutes
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